Bad Pharma: How drug companies mislead doctors and harm patients [Paperback]

This is an impressive book on a serious subject which at times really is a matter of life and death. It can be read by anyone interested in the pharmaceutical industry, and doesn't require any previous knowledge of medicine or even science in general.

The tone is chatty enough to keep you interested, while remaining relatively well structured. I think you will get an idea of whether you would enjoy this book by first watching either of Ben Goldacre's TED talks: if you finish watching them and think "I want to know more" then this book is going to be just the thing for you.

There is no hint of conspiracy theory in this book. Goldacre sticks to a sober recounting of the problems, and he is meticulous about backing up what he says with references, with particular emphasis on systematic reviews, which is important given the subject matter of the book. He never gets into politics, but concentrates on actual, proven real-world harms and benefits.

I also appreciate that despite the massive size of the problems he's describing, he manages to avoid despair and gives recommendations appropriate for the different sections of his readership. I thought the section on conflicts of interest was subtly thought-out and proves that Goldacre is not simply "anti-pharma" and has considered carefully how things could actually be changed in practice.

It's by no means an uplifting and easy read, but it is a fantastic book and fully worth the effort. And who knows, even if you're not a healthcare professional, you may be able to contribute to solving these problems by raising awareness.

Disclosure: I do patient reported outcomes research for top 20 pharma companies

I love science, and I love medicine. Truly, some of the most incredible inventions of our species have been the successful development of amazing compounds from antibiotics and antiretrovirals to insulin and levodopa to modern biologic drugs which help us to lead better lives despite illness. And yet, somewhere along the way, the industry that has arguably done the most to improve life for human beings (in the developed world at least) has taken a curious deviation away from science, and lost its way. As it turns out, marketing is more effective than science in persuading doctors to write prescriptions, and it's cheaper too. Full scale clinical trials are expensive, career-making (or ending), difficult, and time-consuming, and often fail to deliver anything like the transformational benefits that older (now cheap and generic) pills once did.

In this thoroughly researched, engaging, and intensely catalytic account, psychiatrist and truth-seeker Dr Ben Goldacre systematically diagnoses the faults not just with pharma, but with the entire system of evidence based medicine, in which none of us are blameless.

The broad brush strokes are that:

* Pharma builds clinical trials with what can kindly be described as "gamesmanship", systematically biases the literature by with-holding data, drags its feet to comply with transparency measures, ensures its message is heard clearer and louder than anyone else's, and on occasion gets caught doing things it knows it shouldn't.

* Some doctors, whether through cognitive dissonance, ambition or just plain commercialism, use their own reputation to persuade their colleagues that pharma's drugs are more effective than they really are, allow themselves to be unwittingly beguiled by personable drug reps, and take advantage of free education that is systematically biased rather than pay out of their own pocket to keep up to date

* Regulators are buffeted by their own agendas and are relatively toothless in pursuing bad actors in the system or holding people to account for abusing trust

* Journal editors and peer reviewers let things through that they shouldn't - although as with many of these actors the traditions and systems within which they operate make it hard for them to do their job properly

* Patient charities repeat the lobbying policies of their pharma patrons such as protesting against generics or biosimilars or collaborating with commercial PR firms to lobby for access to expensive drugs

* Just about everyone left over outside that group is in rather an all-too-chummy relationship with the biggest pharma companies and are not well motivated to rock the boat or support whistle blowers.

So far, so doomed, right?

Not so. Each chapter (again, presented with specific case studies, footnotes, and more detail on the badscience.net website) ends with clear instructions on how each of these groups (as well as you, the reader) can do something about this. That's what transforms this from an articulate diatribe to a true call to arms, and for me the clearest set of people who can influence this are the patients.

Never will you find another group of people who are so clearly "aligned" to ensure that the entire product of the pharmaceutical industry is better outcomes, instead of higher sales volume. With the right support, patients can spot the holes in trial protocols, they can lobby their patient organisations, they can ask their doctors awkward questions, and whether they know it yet or not they're also the ones with the biggest lever here. Pharma needs patients to volunteer for trials, to be adherent to their medications, and to be engaged enough in their condition to want to be talking to their doctor about the right treatment for them. With a book like this as their guide, no empowered patient can have any doubt about where to make a start.

And everyone else? We should read this book to know how to support them, prepare institutions to mediate the new dialogue, and prepare for the rehabilitation of "bad pharma" to help the companies that really mean to do so to reassert their moral authority and honor the social contract they've been given. There really is no other path to take.

A new drug is developed. You want to find out if it works. How can you tell? The answer is that you count. You take two groups of people with the illness, which you hope your drug will treat. You give one of them the drug and the other with a sugar pill. You count and compare the results. Who gets better and who stays ill in each group? Then you know - as much as one can know for sure - whether the treatment in question actually works.

Well, you do have a good idea if you have done the test fairly. Remember: you must count. If you want to rig the result, then you do not count properly. In science, you must keep a record of the misses as well as the hits. If you want to cheat, then don't count the misses. Only count the hits. Count those who seem to get well after being given your new drug but don't count those who don't. Worse, you don't count bad hits - side effects, for instance, which suggest that your new drug harms rather than cures. Hide unflattering data and only publish the data that make your drug look good.

But that's not all. You can compare your new drug against a placebo as opposed to a decent version of the same drug. You can stop the trial early if you get a run of good results before any bad results spoil things. You can measure surrogate outcomes - i.e. changes in blood pressure - rather than whether people live longer if they get your drug or not. You can pay ghost writers to write up the biased results from your trials and then get academics and medics to rubber-stamp them. You can get your marketing reps to assiduously cultivate doctors who are prepared to promote your particular drug. Those doctors may have already formed a positive view of your particular company's drug independently of your blandishments, but you will make sure they get heard, and the sceptical ones aren't. These are just some of the tricks the book describes. It's not about peddling untruths but half-truths. But the practical effect of this is to debase the evidence upon which doctors must base their decisions.

This book's message is not that the drugs don't work. They do work - sometimes. Or they don't work - sometimes. Or they sometimes work or sometimes don't work, depending on all sorts of factors. But we need evidence to know if they do or if they don't work, or if they only work some of the time. Outright fraud is not the problem (mostly). It's methodological dishonesty, which makes it impossible to tell in all too many cases whether the drug a doctor prescribes has good evidence to tell you whether it is likely to cure or to kill. It does not follow from this dismal state of affairs that quack remedies have been vindicated. They haven't. But the tricks of bad pharma practices are a lot more sophisticated, and harder to detect. Above all else, the scientific method, properly applied can tell us (as far as we can know) whether a given remedy is efficacious or not. It is not the method which is at fault, but its distorted application.

If you believe otherwise, then you are mistaken. A book like this presupposes that there is a difference between truth and falsehood, and that the difference can be detected, with tried and tested means to do so. The trials do speak the truth - if they are not muzzled. To get at the truth, you need a complete picture, not a partial one. If you find a body with a knife in its back, you want to find the killer. Corrupt police may decide to frame an innocent man - but does not mean that there is no way of telling who the culprit was, or there is no such thing as the proper use of evidence in criminal justice. If there is no such thing as objective truth, there is no such thing as a lie. The same with medicine. Dodgy use of the method does not mean the method itself is to blame.

One way we can get at the truth is better collection of data. Data are the bread and butter of science, The excellent Cochrane Library does jut that - collects all the hits and misses. The Library is an entirely voluntary collaboration of doctors, which seeks to gather all the data on particular remedies (not just drugs), and score them on how harmful or helpful they are. It scrutinises all would-be remedies, both mainstream and complementary, to the same cold, objective eye. It is worth looking up (enter Cochrane Library in your search engine). This is how the scientific method is supposed to work. It is a beacon of intellectual rigour and honesty. Goldacre rightly sings its praises.

Goldacre's book is restrained and forensic in its tone. There is no bilious hyperbole, just careful analysis. If you want to read a call for the entire system to torn down, rather than fixed, then this isn't the book for you. If you decide that all mainstream medicine is a fraud and start taking quack remedies, then this also is not the book for you. You'd also be making a decision poorly supported by evidence. But the system is broke. And it's broke because the thing that should be its lifeblood - evidence - has been chocked off in too many places because of dodgy methodology.

He offers plenty of practical suggestions for reform, things we can all do and gives examples of initiatives that have worked (the US is well ahead of the UK in this respect). But this is going to take years to fix. First the fur deserves to fly. Hopefully this book will ruffle a lot of feathers, not just those in the pharma industry, but among pusillanimous regulators and complacent senior medics who really ought to know better.

It will be interesting to see what sort of discussion this book provokes in the next few months. Are the offended parties going to engage with Goldacre in print, or are they going to try and silence him in a libel courts? I'm going to put aside a few quid for his defence fund.